|
|||||
|
|
| 中药大规模临床试验及其管理与质量控制 | |
| 引用本文： | 商洪才,张俊华,戴国华,曹红波,任明,项耀祖,汪洋,张伯礼,李幼平.中药大规模临床试验及其管理与质量控制[J].中西医结合学报,2007,5(1):1-4. |
| 作者姓名： | 商洪才 张俊华 戴国华 曹红波 任明 项耀祖 汪洋 张伯礼 李幼平 |
| 作者单位： | 1. 天津中医药大学临床研究评价中心,天津,300193;四川大学临床医学博士后流动站,四川,成都,610041 2. 天津中医药大学临床研究评价中心,天津,300193 3. 四川大学临床医学博士后流动站,四川,成都,610041;中国循证医学中心,四川,成都,610041 |
| 基金项目： | 国家科技攻关项目;国家自然科学基金 |
| 摘 要： | 大规模临床试验是进行药物临床评价的重要手段之一。本文详细介绍了大规模临床试验的概念及特点,中药大规模临床试验的可能性和必要性以及运行管理与质量控制,并以国家科技攻关项目“芪参益气滴丸对心肌梗死二级预防的临床试验研究”为例加以阐述。 |
| 关 键 词： | 中药 临床试验 管理 质量控制 |
| 文章编号： | 1672-1977（2007）01-0001-04 |
Administration and quality control of large-scale clinical trials of traditional Chinese medicine |
|
| Hong-cai SHANG,Jun-hua ZHANG,Guo-hua DAI,Hong-bo CAO,Ming REN,Yao-zu XIANG,Yang WANG,Bo-li ZHANG,You-ping LI.Administration and quality control of large-scale clinical trials of traditional Chinese medicine[J].Journal of Chinese Integrative Medicine,2007,5(1):1-4. | |
| Authors: | Hong-cai SHANG Jun-hua ZHANG Guo-hua DAI Hong-bo CAO Ming REN Yao-zu XIANG Yang WANG Bo-li ZHANG You-ping LI |
| Institution: | 1. Clinical Research Assessment Centre, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China ;2. Clinical Medicine Post-doctoral Flow Station of Sichuan University, Chengdu, Sichuan Province 610041, China ;3. China Evidence-Based Medicine Centre, Chengdu, Sichuan Province 610041, China |
| Abstract: | Large-scale clinical trial is an important measure of clinical evaluation on drugs. This paper introduces the concept and features of large-scale clinical trial, the possibility and necessity of large-scale clinical trial of traditional Chinese medicine, as well as its administration and quality control, with Myocardial Infarction Secondary Prevention Study in Traditional Chinese Medicine (MISPS-TCM), a National Program Subject, as an example. |
| Keywords: | Chinese herbal drugs clinical trials administration quality control |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ | |